Routine Fiberoptic Light Source Suppliers
Limit companies to: Worldwide USA
Sunoptic Technologies | Address: 6018 Bowdendale Ave., Jacksonville, Florida 32216-6042, USA 
www.sunoptictech.com | Send Inquiry | Phone: +1-(904)-737-7611, 877-677-2832
FDA Registration: 1035968 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 13485, CE Certified
Products: Recording Devices, Fiberoptic Surgical Headlights, Dental Probes, Fiber Optic Lightsources, Fiberoptic Cables, Repair Parts Service, ...
Sunoptic Technologies deals with the development and manufacturing of fiberoptic and illumination products. We offer surgical headlights, lightsources, video cameras, recording devices, fiberoptic cab more...
www.sunoptictech.com | Send Inquiry | Phone: +1-(904)-737-7611, 877-677-2832
FDA Registration: 1035968 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 13485, CE Certified
Products: Recording Devices, Fiberoptic Surgical Headlights, Dental Probes, Fiber Optic Lightsources, Fiberoptic Cables, Repair Parts Service, ...
Sunoptic Technologies deals with the development and manufacturing of fiberoptic and illumination products. We offer surgical headlights, lightsources, video cameras, recording devices, fiberoptic cab more...
Medcam Technology, Inc. | Address: 4586 N. Hiatus Road, Sunrise, Florida 33351, USA
www.medcamtechnology.com | Phone: +1-(954)-742-6140, 888-829-2848
Year Established: 1999 Annual Revenues: USD 1-5 Million
Products: Cameras, Video & Optical Systems, Routine Fiberoptic Light Source (FDA Code: FCW), ...
Medcam Technology, Inc. offers video camera and intregrated light source for medical industry. more...
www.medcamtechnology.com | Phone: +1-(954)-742-6140, 888-829-2848
Year Established: 1999 Annual Revenues: USD 1-5 Million
Products: Cameras, Video & Optical Systems, Routine Fiberoptic Light Source (FDA Code: FCW), ...
Medcam Technology, Inc. offers video camera and intregrated light source for medical industry. more...
Corin U.S.A. | Address: 10500 University Center Dr., Suite 190, Tampa, Florida 33612, USA
www.coringroup.com | Phone: +1-(813)-9774469
FDA Registration: 1056629
Products: Anterior Cruciate Ligament Surgical Reconstruction System, Orthopaedic Implants, Knee Replacement Revision Components, Hip Replacement Instrumentation Kit, Orthopaedic Instruments, Hip Resurfacing Instrument, ...
Corin U.S.A. specializes in manufacturing reconstructive orthopaedic devices. We provide techniques that help to restore mobility and relieve the pain of osteoarthritis. Our products include hip resur more...
www.coringroup.com | Phone: +1-(813)-9774469
FDA Registration: 1056629
Products: Anterior Cruciate Ligament Surgical Reconstruction System, Orthopaedic Implants, Knee Replacement Revision Components, Hip Replacement Instrumentation Kit, Orthopaedic Instruments, Hip Resurfacing Instrument, ...
Corin U.S.A. specializes in manufacturing reconstructive orthopaedic devices. We provide techniques that help to restore mobility and relieve the pain of osteoarthritis. Our products include hip resur more...
Cameron-Miller, Inc. | Address: 5410 West Roosevelt, Road #241, Chicago, Illinois 60644, USA
cameron-miller.com | Send Inquiry | Phone: +1-(773)-379-2624, 800-621-0142
FDA Registration: 1415191 Year Established: 1915 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9000 Certified
Products: Electrosurgical Generators, Disposable Loop Electrodes, Disposable Ball Electrodes, Adapters & Connectors, Universal Cuff Adapter, Diagnostic Equipment, Electrosurgical Forceps, ...
Cameron-Miller, Inc. manufactures surgical and medical instruments. Our product line includes electro-surgical generators, forceps, flexible snares, rigid snares, flexible suction coagulators, rigid s more...
cameron-miller.com | Send Inquiry | Phone: +1-(773)-379-2624, 800-621-0142
FDA Registration: 1415191 Year Established: 1915 Annual Revenues: USD 25-50 Million Employee Count: ~20 Quality: ISO 9000 Certified
Products: Electrosurgical Generators, Disposable Loop Electrodes, Disposable Ball Electrodes, Adapters & Connectors, Universal Cuff Adapter, Diagnostic Equipment, Electrosurgical Forceps, ...
Cameron-Miller, Inc. manufactures surgical and medical instruments. Our product line includes electro-surgical generators, forceps, flexible snares, rigid snares, flexible suction coagulators, rigid s more...
Kavo Dental Corporation | Address: 340 East Main Street, Lake Zurich, Illinois 60047, USA
www.kavousa.com | Send Inquiry | Phone: +1-(847)-550-6800, (800)-323-8029
Year Established: 1909 Annual Revenues: USD 1-5 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Autoclaves, Extractors, General Medical Supplies, Top Loading Autoclaves, Programmable Autoclaves, Automatic Autoclaves, ...
Kavo Dental Corporation supplies diagnostic devices, operatory equipment & laboratory products. Our diagnodent aids in the detection of caries. Even very small lesions are detected at the earliest sta more...
www.kavousa.com | Send Inquiry | Phone: +1-(847)-550-6800, (800)-323-8029
Year Established: 1909 Annual Revenues: USD 1-5 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Autoclaves, Extractors, General Medical Supplies, Top Loading Autoclaves, Programmable Autoclaves, Automatic Autoclaves, ...
Kavo Dental Corporation supplies diagnostic devices, operatory equipment & laboratory products. Our diagnodent aids in the detection of caries. Even very small lesions are detected at the earliest sta more...
Prosolv CardioVascular | Address: 8021 Knue Rd, Suite 100, Indianapolis, Indiana 46205, USA
www.prosolv.com | Send Inquiry | Phone: +1-(317)-594-7431
Products: Software Programs, Picture Archiving & Communications Systems, Picture Archiving System Installation Service, Radiological Image Processing System (FDA Code: LLZ), Radiographic Intensifying Screen (FDA Code: EAM), Mammographic X-Ray System Full Field Digital (FDA Code: MUE), ...
Prosolv CardioVascular deals in multi-modality image review, analysis and user-defined customized reports in a non-proprietary, open architecture environment. We support all DICOM and HL7 integrations more...
www.prosolv.com | Send Inquiry | Phone: +1-(317)-594-7431
Products: Software Programs, Picture Archiving & Communications Systems, Picture Archiving System Installation Service, Radiological Image Processing System (FDA Code: LLZ), Radiographic Intensifying Screen (FDA Code: EAM), Mammographic X-Ray System Full Field Digital (FDA Code: MUE), ...
Prosolv CardioVascular deals in multi-modality image review, analysis and user-defined customized reports in a non-proprietary, open architecture environment. We support all DICOM and HL7 integrations more...
QED | Address: 750 Enterprise Dr., Lexington, Kentucky 40510, USA
www.qedisit.com | Send Inquiry | Phone: +1-(800)-513-2256
FDA Registration: 1037039
Products: Fiberoptic Surgical Headlights, Fiber Optic Headlight Systems, Halogen Power Light Source, AC-Powered Operating Headlamp (FDA Code: HPQ), Battery-Operated Operating Headlamp (FDA Code: HPP), Fiberoptic Focusing Headlight (FDA Code: FCT), ...
QED deals with light sources, fiber optic headlights, and halogen headlights. Our halogen headlights are ideal for operating room and in-office procedures. Their right angled design eliminates cantile more...
www.qedisit.com | Send Inquiry | Phone: +1-(800)-513-2256
FDA Registration: 1037039
Products: Fiberoptic Surgical Headlights, Fiber Optic Headlight Systems, Halogen Power Light Source, AC-Powered Operating Headlamp (FDA Code: HPQ), Battery-Operated Operating Headlamp (FDA Code: HPP), Fiberoptic Focusing Headlight (FDA Code: FCT), ...
QED deals with light sources, fiber optic headlights, and halogen headlights. Our halogen headlights are ideal for operating room and in-office procedures. Their right angled design eliminates cantile more...
Progressive Dynamics Medical, Inc. | Address: 507 Industrial Rd., Marshall, Michigan 49068-1758, USA
www.progressivedynamicsmedical.com | Send Inquiry | Phone: +1-(269)-781-4241
Year Established: 1964 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Forced-air Warming Units, Fiberoptic Surgical Light (FDA Code: FST), Contract Manufacturing, Endoscopic Light Source, Fiberoptic Light Source & Carrier (FDA Code: EQH), Fiberoptic Illuminator for Endoscope (FDA Code: FFS), ...
Progressive Dynamics Medical, Inc. produces power converters and battery charging systems for the RV industry. We have introduced several series of interior lighting products designed for both the RV more...
www.progressivedynamicsmedical.com | Send Inquiry | Phone: +1-(269)-781-4241
Year Established: 1964 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Forced-air Warming Units, Fiberoptic Surgical Light (FDA Code: FST), Contract Manufacturing, Endoscopic Light Source, Fiberoptic Light Source & Carrier (FDA Code: EQH), Fiberoptic Illuminator for Endoscope (FDA Code: FFS), ...
Progressive Dynamics Medical, Inc. produces power converters and battery charging systems for the RV industry. We have introduced several series of interior lighting products designed for both the RV more...
Pentax Southern Region Service Center | Address: 8934 Kirby Dr., Houston, Texas 77054, USA
Phone: +1-(201)-571-2300
Products: Cystoscopes, Confocal Imaging System, Colonoscopes, Gastroscope, Bronchoscopes, Endoscope Accessories (FDA Code: KOG), ...
Pentax Southern Region Service Center specializes in offering Pentax add-in cameras. Our products include bronchoscope, choledochoscope, colonoscope , confocal system, cystoscope, endoscope accessorie more...
Phone: +1-(201)-571-2300
Products: Cystoscopes, Confocal Imaging System, Colonoscopes, Gastroscope, Bronchoscopes, Endoscope Accessories (FDA Code: KOG), ...
Pentax Southern Region Service Center specializes in offering Pentax add-in cameras. Our products include bronchoscope, choledochoscope, colonoscope , confocal system, cystoscope, endoscope accessorie more...
Cardiac Services Ltd. | Address: 10 Falcon Rd.d. S., Boucher Rd., Belfast BT12 6RD, United Kingdom 
Phone: +44-(028)-9066-9000
Employee Count: ~40
Products: Non Invasive External Transcutaneous Cardiac Pacemaker (FDA Code: DRO), Presurgery Imaging Computer, Cryotherapy Unit (FDA Code: HQA), Routine Fiberoptic Light Source (FDA Code: FCW), ...
Cardiac Services Ltd. offers pre-surgery imaging computers, cryotherapy units, non-invasive external transcutaneous cardiac pacemakers and routine fiberoptic light sources. more...
Phone: +44-(028)-9066-9000
Employee Count: ~40
Products: Non Invasive External Transcutaneous Cardiac Pacemaker (FDA Code: DRO), Presurgery Imaging Computer, Cryotherapy Unit (FDA Code: HQA), Routine Fiberoptic Light Source (FDA Code: FCW), ...
Cardiac Services Ltd. offers pre-surgery imaging computers, cryotherapy units, non-invasive external transcutaneous cardiac pacemakers and routine fiberoptic light sources. more...
Grieshaber & Co. AG | Address: Winkelriedstr 52, Schaffhausen 8203, Switzerland
Phone: +41-(52)-632-3434
Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Micro Ophthalmic Scissors, Ophthalmic Instrument Stand (FDA Code: HMG), Ophthalmic Suture Scissors (FDA Code: HNF), Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Grieshaber & Co. AG specializes in offering ophthalmic surgical instruments. We offer iris retractors for use in surgical procedure on the eye of a living being. We also offer device for improving dra more...
Phone: +41-(52)-632-3434
Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Micro Ophthalmic Scissors, Ophthalmic Instrument Stand (FDA Code: HMG), Ophthalmic Suture Scissors (FDA Code: HNF), Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Ophthalmic Cannula (FDA Code: HMX), Surgical Ophthalmic Cannula (FDA Code: HMX), ...
Grieshaber & Co. AG specializes in offering ophthalmic surgical instruments. We offer iris retractors for use in surgical procedure on the eye of a living being. We also offer device for improving dra more...
Kelsar, S.A. | Address: Blvd. Insurgentes, Libriamento a La, La Mesa 37, Tijuana 22450, Mexico
Phone: +52-(0)-89-41-86
FDA Registration: 9610849
Products: Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Staplers, Open Clip Appliers, Surgical Staplers, Laparoscopic Staplers, Automatic Surgical Stapler (FDA Code: GAG), ...
Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids fr more...
Phone: +52-(0)-89-41-86
FDA Registration: 9610849
Products: Surgical Staplers, Circular Staplers, Surgical Staplers, Titanium Staples, Surgical Staplers, Stainless Steel Staples, Surgical Staplers, Open Clip Appliers, Surgical Staplers, Laparoscopic Staplers, Automatic Surgical Stapler (FDA Code: GAG), ...
Kelsar, S.A. specializes in offering catheter bags, intraventricular probes and oxygen & bag feeder. Our Argyle DeLee suction catheter with mucous trap is intended to aspirate liquids or semisolids fr more...
Olympus Imaging Corporation | Address: 3-1 Nishi-Shinjuku 2-chome, Shinjuku-ku, Tokyo 163-0914, Japan
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code: GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Non Rigid Laryngoscope (FDA Code: CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
www.olympus.co.jp | Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code: GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code: EOQ), Non Rigid Laryngoscope (FDA Code: CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information more...
Endomed Endoskopie + Video GmbH | Address: Akazienweg 19, Alsbach D-64665, Germany 
www.endomed.de | Send Inquiry | Phone: +49-(6257)-93180
FDA Registration: 3010666400 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Ultrasonic Surgical Aspirator, Miniature Ultrasonic Surgical Aspirator, Surgical Aspirator, Surgical Aspirator Tips, Flash Light Source, Endoscopic Still Camera (FDA Code: FXM), ...
Endomed Endoskopie + Video GmbH specializes in the production and sale of endoscopy systems. We provide an entire range from entry model for medical practitioners to high-end video systems for hospita more...
www.endomed.de | Send Inquiry | Phone: +49-(6257)-93180
FDA Registration: 3010666400 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Ultrasonic Surgical Aspirator, Miniature Ultrasonic Surgical Aspirator, Surgical Aspirator, Surgical Aspirator Tips, Flash Light Source, Endoscopic Still Camera (FDA Code: FXM), ...
Endomed Endoskopie + Video GmbH specializes in the production and sale of endoscopy systems. We provide an entire range from entry model for medical practitioners to high-end video systems for hospita more...
Welch Allyn GmbH & Co. KG | Address: Zollerstrasse 2-4, Jungingen D-72417, Germany
www.welchallyn.com/regions/europe/germany/default.htm | Send Inquiry | Phone: +49-(7477)-927186
Annual Revenues: USD 10-25 Million Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood pressure Cuffs (FDA Code: DXQ), Blood Pressure Cuffs With Bayonet Connectors, Blood Pressure Cuff With Inflation Systems, Blood Pressure Cuffs and Neoprene Bladders (1-Tube), Blood Pressure Cuffs and Neoprene Bladders (2-Tube), Blood Pressure Cuff Barriers, ...
Welch Allyn GmbH & Co. KG is a manufacturer of medical devices, products and solutions used by caregivers in doctors' offices, hospitals & emergency response settings. Pocket Junior otoscope is a ligh more...
www.welchallyn.com/regions/europe/germany/default.htm | Send Inquiry | Phone: +49-(7477)-927186
Annual Revenues: USD 10-25 Million Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood pressure Cuffs (FDA Code: DXQ), Blood Pressure Cuffs With Bayonet Connectors, Blood Pressure Cuff With Inflation Systems, Blood Pressure Cuffs and Neoprene Bladders (1-Tube), Blood Pressure Cuffs and Neoprene Bladders (2-Tube), Blood Pressure Cuff Barriers, ...
Welch Allyn GmbH & Co. KG is a manufacturer of medical devices, products and solutions used by caregivers in doctors' offices, hospitals & emergency response settings. Pocket Junior otoscope is a ligh more...
Stryker Trauma Gmbh | Address: Prof.-Kuentscher-Strasse 1-5, Schoenkirchen D-24232, Germany
Phone: +49-(4348)-702-0
FDA Registration: 9610622 Year Established: 1941
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Invasive Traction Component (FDA Code: JEC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ), ...
Stryker Trauma GmbH offers orthopedic manual surgical instruments, pneumatic orthopedic power tool systems, screws and staples. more...
Phone: +49-(4348)-702-0
FDA Registration: 9610622 Year Established: 1941
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Invasive Traction Component (FDA Code: JEC), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Pneumatic Powered Orthopedic Surgical Instrument & Accessory (FDA Code: HSZ), ...
Stryker Trauma GmbH offers orthopedic manual surgical instruments, pneumatic orthopedic power tool systems, screws and staples. more...
Erchinger Medizintecnik | Address: Rudolf-Diesel-Str. 20, Tuttlingen 78532, Germany
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Nasal Rasps (FDA Code: KBA), Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Phone: +49-(7461)-3243
FDA Registration: 9611827
Products: ENT Syringe (FDA Code: KCP), Ear Syringes Repair Service, Nasal Rasps (FDA Code: KBA), Baby Ear Syringe, Electric Ear Syringe, ENT Irrigation Syringe (FDA Code: KCP), ...
Erchinger Medizintecnik specializes in offering hemorrhoidal suction ligators. Our products include ENT injection syringes, urological catheters, ENT suction tube, surgical needle guides, trocars for more...
Karl Storz GmbH & Co. KG. | Address: Mittelstr. 8, 78532 Tuttlingen, Postfach 230, Tuttlingen 78503, Germany
www.karlstorz.com | Send Inquiry | Phone: +49-(7461)-708-0
FDA Registration: 9614434 Employee Count: ~2000 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Flexible, Rigid, Cameras, Cystoscopes, Nephroscopes, Percutaneous Nephroscopes, ...
Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applicatio more...
www.karlstorz.com | Send Inquiry | Phone: +49-(7461)-708-0
FDA Registration: 9614434 Employee Count: ~2000 Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Flexible, Rigid, Cameras, Cystoscopes, Nephroscopes, Percutaneous Nephroscopes, ...
Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applicatio more...
Medicon eG | Address: Postfach 44 55, Tuttlingen D-78509, Germany
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
www.medicon.de | Send Inquiry | Phone: +49-(0)-7462/20-09-0
FDA Registration: 8010099 Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Clamps, Curettes, Forceps (FDA Code: HTD), Scissors, Titanium Plating Systems, Pituitary Scoops, ...
Medicon eG specializes in the production of surgical tools. We offer a wide range of instruments for anaesthesia. Our modified magill forceps are characterised by atraumatic jaws that render safe and more...
Rotolux Enterprises Inc. | Address: 4145 North Service Rd, Ste. 200, Burlington, Ontario L7L 6A3, Canada 
Send Inquiry | Phone: +1-(905)-659-2816
Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Arthroscopes (FDA Code: HRX), Fiberoptic Cables, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Incandescent Endoscopic Lamp (FDA Code: FTI), Hysteroscope and Accessories (FDA Code: HIH), Flexible/Rigid Cystoscope and Accessories (FDA Code: FAJ), ...
Rotolux Enterprises Inc. is associated with arthroscopes, fiberoptic cables, general & plastic surgery laparoscopes, hysteroscopes & accessories. more...
Send Inquiry | Phone: +1-(905)-659-2816
Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Arthroscopes (FDA Code: HRX), Fiberoptic Cables, General & Plastic Surgery Laparoscope (FDA Code: GCJ), Incandescent Endoscopic Lamp (FDA Code: FTI), Hysteroscope and Accessories (FDA Code: HIH), Flexible/Rigid Cystoscope and Accessories (FDA Code: FAJ), ...
Rotolux Enterprises Inc. is associated with arthroscopes, fiberoptic cables, general & plastic surgery laparoscopes, hysteroscopes & accessories. more...
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FDA Code / Regulation: FCW / 876.1500
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification. (1) Class II (performance standards).
